|Posted by Salah Alkhallagi on January 3, 2016 at 1:02 AM||comments (17)|
Engineers and technicians are not always known for their ability to write good reports. To help you out with your end-of-year obligations, 24×7 offer some guidelines. Here is what advised.
|Posted by Salah Alkhallagi on September 9, 2015 at 12:57 AM||comments (0)|
Published on September 4, 2015
By William Hyman, ScD
Medical devices follow clear paths to market, beginning with design and progressing through regulatory action by the FDA. In most cases, this happens before biomeds become involved with devices, although biomeds may be involved in clinical trials and are involved in postmarket FDA measures, such as Medical Device Reporting (MDR) and recalls. Repair activities may also touch on regulatory issues such as manufacturer assertions, correct or not, that certain things can or can’t be done because of FDA restrictions. Repair parts may also raise regulatory issues, as illustrated recently with respect to an FDA Warning Letter to a replacement battery company and the recall of parts from a non-OEM supplier.
Biomeds should also play a strong role in device selection. In doing so, it can be helpful to understand the two major ways in which devices negotiate the FDA regulatory system, and the implications of those two paths with respect to how much scrutiny a device received from the FDA before it reached the market. It is here that the two important and distinct labels of “cleared” or “approved” come into play. I will argue that this distinction is not one only for an academic (like me), nor one that only a regulatory geek should care about. But first, a brief background.
All medical devices are divided into one of three classes, cleverly called Class I, Class II, and Class III. Class I devices are the simplest, and come to market without any review by the FDA. Most Class II devices are subject to FDA “premarket notification,” which is commonly called a “510(k)” after the section of the applicable law. Devices that go through the 510(k) process have to argue to the FDA that they are substantially equivalent to some other legally marketed Class II device. This process usually does not require a clinical trial. “Substantially equivalent” does not mean identical, and sometimes considerable differences are allowed. When a 510(k) process is successful, the device is properly said to be “cleared” but it is not “approved.” Class III devices are subject to premarket approval, or PMA. A PMA usually requires a full clinical trial to actually prove that the device is safe and effective.
When selecting a medical device, it is good to know what class the device is and what route to market it underwent. It is good practice to ask the sales rep for the product’s class, as well as the applicable 510(k) or PMA number. Even if the rep looks confused, he or she should be willing to find out for you. While you’re at it, ask for the applicable three-letter FDA product code. This information can be helpful when looking up devices on many of the FDA’s databases, including Manufacturer and User Facility Device Experience (MAUDE), Recalls, and Total Product Life Cycle. The latter can be useful because it displays all vendors, recalls, and a table of reported device problems.
In most cases, all devices of a type being considered for purchase will have the same product code, so class and cleared or approved status will not be a decision factor. However, obtaining this information can be helpful with respect to learning how forthcoming the sales reps are, and in communicating accurately with others. Moreover, I assert that biomeds and others should use the proper terminology, because the terminology has real meaning.
Aside from direct equipment selection, the implications of this difference in FDA scrutiny can be used to educate clinical staff about the devices that they use. Then, doctors perhaps won’t be surprised when they learn that devices such as morcellators and duodenoscopes were never subjected to a full clinical trial, and that such devices were not “approved” by the FDA. Similarly, implanted devices such as metal-on-metals hips and surgical meshes were never “approved.” One reason doctors are often surprised by the lack of clinical trials for cleared devices may be that doctors know more about drugs. Since all new drugs are approved, they may assume that this is also true for medical devices.
Most companies use the correct terminology, but the medical device press (although I haven’t caught 24×7 doing it) and lay press are not always as careful. (A New York Times writer once responded to my criticism in this regard by saying that yes, he knew the difference, but his readers would just be confused by it.) Clinical journals also often get it wrong.
In this regard, biomeds can serve in an educational role by always using the correct word, and helping others understand the difference. Biomeds should also understand the potential regulatory issues around non-OEM replacement parts, and at least bring up the issue with their parts suppliers.
Some, and it turns out most, devices are “cleared” and some are “approved,” and there is a difference. You are probably a geek anyway (in the good sense), so add this distinction to your geeky vocabulary and practice.
William A Hyman, ScD, is professor emeritus, Biomedical Engineering, at Texas A&M University, College Station, Tex, and adjunct professor of Biomedical Engineering at The Cooper Union, New York.
|Posted by Salah Alkhallagi on August 11, 2015 at 6:47 AM||comments (0)|
Published on November 16, 2014
By David Harrington, PhD
Photo of Dave HarringtonIt’s the fashion nowadays to describe what we biomeds and clinical engineers do as “healthcare technology management.” I know that my opinion may not be very popular, but I think the name does an injustice to us and to what we do best. Let me explain.
I will admit to being old and somewhat stubborn when it comes to our profession. When I entered the healthcare engineering field in 1962 (not 1862, as some may think), our function was to make items that were needed to treat sick patients, but always keeping in mind the admonition to first do no harm to those patients. Over the years, my fellow healthcare engineers developed some great technology that has saved countless lives and made the quality of life for many people so much better. We would go to meetings and freely talk about what we were working on and seek input from others. (Remember, this was before the Internet, fax, cell phones, and a multitude of publications on every specialty in medicine.)
A Series of Setbacks
Many of those designs were passed on to manufacturers. They marketed those devices, and healthcare jumped forward. Then there was a series of setbacks. One of the big ones was an article published in 1971 in that great technical journal, Ladies Home Journal, by Ralph Nader, called “Ralph Nader’s Greatest Exposé.” In it, he claimed that thousands of people were killed in hospitals every year by micro shock. Now, if anyone has any proof that a person was killed by micro shock from a medical device, please publish that information. Forty years with no proof is long enough to hold onto an error in data collection.
This development was a step in the wrong direction, as hospital lawyers—and I intend no comment on their value to healthcare—got involved and pushed hospital administrations to have every device tested on a regular schedule. This reaction led to another jump in health technology management positions—in my opinion, a waste of time and money. Then there was that group out of an Eastern state that was issuing ratings of devices and suggesting potential problems, and that was followed in 1976 by Public Law 94-295, better known as the Medical Device Amendments of 1976.
In its aftermath, where it used to take days to get a device to a patient, it now took months and, in many cases, years. The law added huge costs to the system, and had a significant repercussion on our profession: Healthcare technology management groups now had more perceived need to manage technology, rather than focusing on what was best for the patients and keeping costs down.
Are the Managers Succeeding?
One of the notable features of healthcare technology management is benchmarking. Well, I have yet to see a single publication or presentation showing that benchmarking has improved patient care, cut costs, or done anything else of true value. If the “managers” doing this work found value, you think that it would have been shared. A lot of the blame for not getting good information out to us all lies with the big institutions and service organizations that supposedly gather data but never share it outside of their groups.
It has been close to 25 years since some of the early “technology managers” started pushing the concept that all medical devices would be interconnected. The result of this development would be that data would flow easily and accurately between all devices, medical records, and, of course, the billing databases, reducing costs and improving patient care. They are closer than they once were, but we still have to fill out all sorts of paperwork every time we go to a doctor or get a flu shot. Outstanding HTM on this one! The fact that we still have so far to go after 25 years makes you wonder what these “managers” are doing.
Another pet peeve of mine involves the process for dealing with the Year 2000 (Y2K) problem. We poor, underappreciated biomeds and engineers worked long and hard making sure that the equipment we were responsible for would work, and that patient care would be continuous. We did all of that at a cost of about 10% of what the IT people spent. Plus, they have replaced the equipment they purchased back then at least twice in the last 15 years, while we still keep our technology working and safe for patients. Again, the managers were wrong and we were right. But who gets all the credit? Not us.
Keep Calm and Carry On
But we do have the comfort of knowing that our work helps so many people get better and we are always cost driven. If the OEM is trying to overcharge us for a part, we go to all the second sources that we know of to get that part and install it so patient care can continue.
And now we have had our profession renamed “healthcare technology management” by those who probably could not do any repairs or assist a nurse or help a physician treat a patient. Regardless, we will continue our work, knowing that what we do is very important and that anyone can be a manager or “leader.” Don’t believe that? Just look at Congress!
In closing, my wife and I are getting close to the age when we will need an increasing level of healthcare, which includes technology. So to all you technical people, thank you for your past services. We hope you are still around when we need you in the future (and that you learn how to use those 3D printers, since many of the new devices we will need will be generated on them). To the managers out there, I would just say this: Please stay out of the way of the technical people so they can do their jobs to support and improve healthcare.
Source: 24x7 Magazine
|Posted by Salah Alkhallagi on August 11, 2015 at 1:52 AM||comments (1)|
Published on August 6, 2015
BMETs in Low-Resource CountriesA new report proposes that skilled biomedical equipment technicians (BMETs) are crucial to advancing healthcare in low-resource countries around the world. The report, “BMETs in Low-Resource Countries,” which was prepared for the GE Foundation and the AAMI Foundation, calls on a wide variety of stakeholders to come together to support the development of “scalable, replicable, and sustainable” training models for such professionals.
The BMET report is a summary of a 2-day meeting held in June 2015 in Toronto, Canada, at which 55 professionals from various backgrounds and countries engaged in discussions that addressed how best to achieve effective training for BMETs in countries that need their services.
According to the report, “without technology that supports diagnosis and treatment, patients are vulnerable to needless pain and suffering, poor health outcomes, and even death.” The report outlines how better access to emergency care and the use of diagnostic and therapeutic tools would reduce patient mortality in many low-resource countries, yet much of the available equipment in such locations is not functional.
As summarized in the report, the stakeholders at the June 2015 meeting concluded that until there are more skilled BMETs on the ground to keep medical equipment running safely and effectively, developing countries will be stymied in their efforts to improve patient care. Toward that end, the meeting participants identified six crucial next steps, which are:
Create an international advisory body to assure quality of BMET training based on core competencies.
Create a global alliance that focuses on the promotion of the HTM profession in low-resource countries.
Ensure the strict selection of BMET trainees/trainers.
Engage multiple stakeholders and funders to promote BMETs.
Create sustainable, scalable funding strategies for BMET training to improve public health outcomes.
Define metrics for BMET health impact/outcomes.
The report emphasizes that successful training programs must encompass the student life cycle from pre-admission to professional BMET. Further, the report recommends that such programs use local trainers who are “able to converse in the local language, understand local customs, and have a local network on which to rely.”
The report also identifies several other factors that would be crucial to success for training models, including the need for constant evaluation, trainer fluency in both theoretical and practical knowledge, and an understanding of infrastructure challenges.
A final report, which will include specific recommendations for the training models, is due to the GE Foundation in October 2015.
|Posted by Salah Alkhallagi on July 9, 2015 at 3:37 AM||comments (0)|
Published on July 2, 2015
By Clarice M. Balconi-Lamica
I was in sixth grade when I decided I wanted to be a biomedical engineer. Before then I thought I would pursue medical school, but once I learned about the biomedical engineering profession, how it fuses both modern medicine and modern technology, I was captivated.
The biomedical world I originally envisioned was one of research and development. But once I graduated from university, I realized I wanted a job where my work in the morning would have a direct impact on people in the afternoon. I found it in the best-kept secret in healthcare: the role of the hospital biomedical engineer. Continue reading...
|Posted by Salah Alkhallagi on June 2, 2015 at 3:37 AM||comments (0)|
Published on May 20, 2015
By John Bethune
The idea that technical skills define biomed performance is baked into the job title, whether it’s biomedical equipment technician or healthcare technology management professional. But in recent years, as the field has struggled to move out of the basement and gain more influence and respect, the importance of people skills has become increasingly clear. And at the heart of people skills, says Barbara Christe, PhD, of Indiana University-Purdue University Indianapolis (IUPUI), is empathy.
“The Secret Sauce Is Professional Empathy: Measuring and Improving the Vital Workplace Characteristic.” Continue reading..
|Posted by Salah Alkhallagi on May 13, 2015 at 2:47 AM||comments (0)|
By Nader Hammoud
Published on May 11, 2015
During the last 3 years since moving to the United States, I have seen different organizations with different management styles. During the 12 years before that, I also observed several organizations internationally, especially in the Middle East and North Africa region.
In third-world countries, the biomed is seen as the gatekeeper for patient safety in a hospital. The biomedical department does not report to facilities or IT; the biomedical department is a separate entity raised to the same level, if not even higher sometimes. Whether a health care organization is remodeling an old OR or starting up a new hospital, the biomed gives the last signature on the “safe to use” documents, just before the CEO’s stamp. This is simply because biomeds understand the importance of what facilities and IT do, and they are the only people in-house qualified to verify that everything is safe for patients. Continue reading
|Posted by Salah Alkhallagi on May 3, 2015 at 6:17 AM||comments (0)|
The Biomedical Technician (BMET) field will grow by roughly 30% by 2022, according to the U.S. Bureau of Labor Statistics; a fact that’s openly promoted to young engineers in videos (like this one) from the Association for the Advancement of Medical Instrumentation (AAMI). And rightly so, the healthcare industry is seeing rapid growth in new technology and—with a growth in the aging U.S. population—more demand for engineers to manage that technology. Continue reading
|Posted by Salah Alkhallagi on May 3, 2015 at 6:12 AM||comments (0)|
Evaluating Computerized Maintenance Management Systems (CMMS) can be a challenging process, especially when you're looking for healthcare specialization and more than basic break-fix capabilities. In TechNation magazine's article titled "Roundtable: CMMS Software", industry leaders recommend some key questions to ask when you start evaluating CMMS software.
Here are some of our favorites:
1. Where is your department going to be in 10 years?
2. How can CMMS impact larger hospital challenges?
3. How comprehensive are the CMMS’ reporting and dashboards?
4. Is the system truly an enterprise solution?
|Posted by Salah Alkhallagi on May 3, 2015 at 1:42 AM||comments (0)|
Healthcare Technology Management (HTM) professionals are vital members of any world-class healthcare delivery team. Clinical engineers, biomedical equipment technicians, and other highly skilled professionals use their expertise to ensure the safety, efficacy, and availability of life-saving healthcare technologies, while keeping healthcare costs down.
Working with clinicians and other healthcare professionals to ensure the highest standards and best practices in medical device safety, security, interoperability and functionality, HTM professionals are responsible for providing a wide array of service offerings.
The Impact of HTM
Whether advising on the purchase, management, or repair of medical devices and technologies, or providing clinical staff with on-call technical assistance, HTM professionals impact the entire health system. Continue reading